Blog | 3/13/2026

Sharp Strategy Spotlight: March 13, 2026

Strategic perspectives on the trends, policies, and ideas shaping healthcare.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on March 12, 2026. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

Dr. Oz says Obamacare enrollment may be 'too high'

  • Although Obamacare sign-ups have fallen significantly this year over skyrocketing monthly premiums, Dr. Mehmet Oz believes enrollment is still too high. Oz, the Trump administration’s top official overseeing the Affordable Care Act, told NBC News that millions of people may be fraudulently enrolled or eligible for other types of coverage.
  • About 23 million people signed up for ACA coverage during this year’s open enrollment period, which ended in January, according to the latest data from the Centers for Medicare and Medicaid Services. That’s roughly 1.2 million to 1.3 million fewer sign-ups than last year. ACA coverage typically appeals to people who are self-employed or don’t get coverage through their jobs.
  • In a phone interview, Oz said some people enrolled in ACA plans should not be there and expects enrollment to fall further — to around 19 million.
  • “In fact, the fact that we have 23 million makes me think we have too many participants in the ACA,” Oz said. “It’s too high of a number.”
  • Oz believes some of ACA’s enrollment may stem from fraud in the sign-up process, as well as cases where people were enrolled by mistake, were signed up for duplicate coverage or received tax credits they didn’t qualify for. Others, he said, may qualify for Medicaid or could obtain insurance through a job but instead choose ACA plans.
  • https://www.nbcnews.com/health/health-news/dr-oz-trump-obamacare-aca-insurance-fraud-deductible-plans-rcna262468

FDA consolidates adverse events reporting systems

  • The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the move would modernize adverse event reporting systems and provide more transparency.
  • The FDA launched AEMS on 11 March, which aims to allow users to view adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food on a single dashboard. The agency said that over the coming months, all other product centers will begin processing adverse event reports in AEMS, and by the end of May, the system will contain real-time adverse event reports for all products it regulates.
  • AEMS will replace the FDA Adverse Event Reporting System (FAERS), Vaccine Adverse Event Reporting System (VAERS), and Adverse Event Reporting System (AERS). By May, the agency will also use AEMS to replace the Manufacturer and User Facility Device Experience (MAUDE), Human Foods Complaint System (HFCS), and Center for Tobacco Products Adverse Event Reporting System (CTPAE).
  • The FDA said it will migrate historical adverse event data to AEMS while decommissioning legacy systems and will develop application programming interfaces (APIs) and data analytics tools to enable users to analyze data using the new system.
  • Press: https://www.raps.org/news-and-articles/news-articles/2026/3/fda-consolidates-adverse-events-reporting-systems
  • FDA Press: https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool

Congress plans new response to health cyberattacks

  • Two years after the seismic Change Healthcare cyberattack, Congress is advancing a plan to safeguard against the kind of hacks that can expose millions of people's private data and cripple health systems.
  • Why it matters: The bipartisan plan puts the burden on the government and providers to prevent the kind of breach that reverberates across the entire industry, jeopardizing patient access to needed treatments and costing hospitals billions.
  • Driving the news: The Senate's health committee late last month advanced legislation to fortify health care cybersecurity in a strong 22-1 vote.
    • The bill would improve coordination among government agencies and requires the Department of Health and Human Services to develop an incident response plan.
    • It also would establish new grants to health entities for cyberattack planning and response and make them use multi-factor authentication and encryption — a key shortcoming exposed by the Change breach.
  • What they're saying: "The Change Healthcare cyberattack in 2024 had widespread impacts on patient care," said Sen. Bill Cassidy (R-La.), chair of the health committee and a lead sponsor of the measure. "This bill enhances cybersecurity across the health care system to better withstand these attacks."
  • https://www.axios.com/2026/03/09/congress-health-cyberattacks-cyber-security   (subscription required for full text)      

FDA vaccine advisers to meet to recommend strains for fall flu shots

  • For the first [time] since the Biden administration, independent vaccine advisers will meet tomorrow to recommend which strains of influenza virus to include in flu vaccines this fall.
  • The Food and Drug Administration (FDA) canceled last year’s meeting of the Vaccine and Related Biological Products Advisory Committee (VRBPAC). Instead, the FDA chose influenza strains after a closed-door meeting with federal officials, with no participation from patient advocates, medical groups, manufacturers, or scientists with expertise in vaccines.
  • Flu shots need to be updated every year because the virus mutates so rapidly.
  • In a document on the FDA website, the agency listed its plans to publish guidance or draft guidance for the pharmaceutical industry on eight vaccine-related topics, including flu shots. The document, dated January 2026, states that one future publication will address “clinical data needed to support the licensure of seasonal inactivated influenza vaccines.”
  • Press: https://www.cidrap.umn.edu/influenza-vaccines/fda-vaccine-advisers-meet-recommend-strains-fall-flu-shots
  • FDA plans: https://www.fda.gov/media/120341/download

Trump administration’s embattled FDA vaccine chief is leaving for the second time

  • The Food and Drug Administration’s embattled vaccine chief, Dr. Vinay Prasad, is once again leaving the agency — the second time in less than a year that he’s departed after controversial decisions involving the review of vaccinations and specialty drugs for rare diseases.
  • FDA Commissioner Marty Makary announced the news to FDA staff in an email late Friday, saying Prasad would depart at the end of April. Makary said Prasad would return to his academic job at the University of California, San Francisco.
  • A longtime academic and critic of the FDA’s standards for drug reviews, Prasad’s approach to regulation since arriving at the FDA last May has confounded many FDA observers and critics.
  • On repeated occasions, Prasad joined Makary in announcing steps to make FDA drug reviews faster and easier for companies. But he also has imposed new warnings and study requirements for some biotech drugs and vaccines, particularly COVID shots that have long been a target for Kennedy, a longtime anti-vaccine activist before joining the Trump administration.
  • https://apnews.com/article/vinay-prasad-fda-trump-vaccine-moderna-fired-bf56fe9852def8c9f1b9a648e5bb92df

GAO calls for greater transparency on high-risk pathogen research

  • A new report from the US Government Accountability Office (GAO) says the Department of Health and Human Services (HHS) should make more information public about how it evaluates and mitigates risks associated with high-risk pathogen research.
  • For the report, GAO reviewed scientific literature, biosecurity reports, and federal oversight processes from 2019 to 2024 related to research that modifies pathogens in ways that can increase their ability to spread or their virulence—the ability to cause disease or bodily harm.
  • The report found disagreement about whether research on pathogens that have the potential to cause a pandemic, sometimes referred to as “gain-of-function research of concern,” has directly contributed to the development of vaccines or other therapeutics.
  • GAO also examined how HHS agencies review and oversee the pathogen research they fund or conduct. It found that while HHS shares some information about high-risk research with federal stakeholders, key details about risk and mitigation measures are not routinely shared with the public.
  • Increasing transparency, the report said, could strengthen public trust and provide greater assurance to the public, the scientific community, and Congress that safeguards are in place to manage the risks associated with dangerous pathogens.
  • GAO recommended that HHS ensure that key information about its risk-review processes, including steps taken to mitigate risks, is publicly shared as appropriate.
  • HHS neither agreed nor disagreed with the recommendation but said it would work to improve transparency about the scope of research involving higher-risk pathogens and the safeguards put in place around it.
  • Press: https://www.cidrap.umn.edu/biosecurity-issues/gao-calls-greater-transparency-high-risk-pathogen-research
  • GAO report: https://www.gao.gov/products/gao-26-107348

Alleged overpayments to Medicare Advantage plans cost seniors billions: Investigation

Trump administration widens its anti-fraud efforts with a Medicaid probe in New York

  • President Donald Trump’s administration is expanding its crackdown on state Medicaid programs to New York, launching a fraud probe in the state a week after it said it was freezing nearly $260 million in Medicaid funding in Minnesota over similar accusations.
  • Centers for Medicare and Medicaid Services Administrator Dr. Mehmet Oz announced Tuesday that the Trump administration identified concerning trends in New York’s Medicaid program and demanded that state officials provide details about their handling of fraud, waste and abuse within 30 days or risk deferred payments.
  • “Heart surgeons are trained to look at the numbers,” Oz, a former celebrity heart surgeon, said in a video on Tuesday. “Right now, the numbers coming out of New York’s Medicaid program don’t add up.”
  • The new investigation is part of an administration-wide initiative to address fraud around the country, which federal officials say is needed to rein in runaway spending and protect taxpayers. With many midterm voters concerned about affordability, Trump has ramped up those efforts, announcing that Vice President JD Vance would help balance the nation’s budget by spearheading a national “war on fraud.”
  • https://apnews.com/article/oz-medicaid-new-york-fraud-investigation-a00bd997ee5b8d839254144377c3b167

Trust in CDC, FDA, NIH shrinks: Survey

  • A poll published Thursday found that Americans have lost trust in federal health institutions and are more likely to say they trust independent, professional medical organizations when it comes to advice on topics like vaccination.
  • The February survey by the Annenberg Public Policy Center (APPC) of the University of Pennsylvania found that public trust in agencies like the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) had fallen by 5 to 7 percentage points in the past year.
  • Public trust in these institutions had been declining prior to 2025, however, having fallen from around 75 percent to 67 percent during the final year of the Biden administration.
  • When it came to public health officials, 38 percent of survey participants said they had some degree of confidence in Health and Human Services Secretary Robert F. Kennedy Jr., with the remaining 62 percent being unconfident.
  • Centers for Medicare and Medicaid Services Administrator Mehmet Oz scored better than Kennedy, with 42 percent expressing some confidence in him and 58 percent saying they were unconfident in him.
  • Press: https://thehill.com/policy/healthcare/5768898-public-health-trust-survey/
  • Survey: https://www.annenbergpublicpolicycenter.org/stark-divide-americans-more-confident-in-career-scientists-at-u-s-health-agencies-than-leaders/

US autism advisory board will not meet in March as scheduled, health agency says

  • A U.S. autism advisory board will not hold a scheduled meeting ​in March, the Department of Health ‌and Human Services said on Saturday.
  • The Interagency Autism Coordinating Committee makes recommendations to the health secretary on federal ​autism research spending and coordinates federal ​autism efforts.
  • The group was scheduled to ⁠meet on March 19.
  • "The IACC will not ​meet later this month," said HHS spokesperson Andrew ​Nixon, without sharing additional details of the cancellation or a new meeting date. "Further information will be shared as ​available."
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-autism-advisory-board-will-not-meet-march-scheduled-health-agency-says-2026-03-07/

CMS Strengthens Patient Protections and Accountability in Organ Donation System

  • The Centers for Medicare & Medicaid Services (CMS) today issued new guidance to strengthen public trust and ensure patients and their families are treated with dignity and care throughout the organ donation process.
  • The guidance clarifies and reinforces the responsibilities of Organ Procurement Organizations (OPOs) and donor hospitals, both in providing patients full medical care regardless of potential donor status and allowing families the time to make decisions regarding organ donation without coercion.
  • This action follows reports that some OPOs have rushed aspects of the organ donation and procurement process, pressuring families to make decisions during moments of grief.
  • CMS will continue strengthened oversight of OPOs through 2027, with these upcoming OPO activities:
    • March 2026 – CMS will highlight national priorities in organ donation and transplantation at the 2026 CMS Quality Conference, reinforcing expectations for access, collaboration, and accountability. Additionally, the public comment period will close on the proposed Conditions for Coverage revisions. See via the Federal Register.
    • Spring 2026 – CMS will publish the 2026 OPO performance reports, based on 2024 data, on CMS QCOR, affirming CMS’s commitment to transparency and public accountability.
    • Summer 2026 – CMS will complete onsite recertification survey reviews for applicable OPOs to ensure compliance with federal standards.
    • Late 2026 (Projected) – CMS anticipates issuing the OPO Conditions for Coverage Final Rule (CMS-3409-P).
  • https://www.cms.gov/newsroom/press-releases/cms-strengthens-patient-protections-accountability-organ-donation-system

CCSQ FY2025–2028 Strategic Roadmap: Optimal Health for All Within Nation’s Health and Long-Term Care Systems

  • The Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS) is committed to improving health care and outcomes, and strengthening accountability, across the nation’s health- and long-term care systems.
  • Over the next several years, CCSQ will focus on five strategic goals—Prevention, Quality and Safety, Coverage Innovation, Data and Technology, and Burden Reduction.
  • These priorities build on CCSQ’s core mission to establish national health and safety standards; implement quality measurement, reporting and improvement; and support Medicare’s coverage determinations.
  • Together, they represent a roadmap for health- and long-term care systems that are safer, stronger, and more transparent.
  • https://www.cms.gov/newsroom/blog/optimal-health-all-within-nations-health-long-term-care-systems-ccsq-fy2025-2028-strategic-roadmap

CMS invites Medicare Part D plans, Medicaid agencies to apply for GLP-1 affordability model

  • CMS issued requests for applications from Medicare Part D plans and state Medicaid agencies to join the voluntary “Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth,” known as BALANCE, model.
  • Under the model, CMS will negotiate with manufacturers on pricing for GLP-1 medications used for weight management and metabolic conditions, acting on behalf of state Medicaid programs and Medicare Part D sponsors. The model builds off the White House’s most-favored-nation pricing agreements with Eli Lilly and Novo Nordisk for drugs that treat obesity, diabetes and related conditions. In December, CMS published a request for applications directed to manufacturers, as well.
  • The participating payers must cover all model drugs from the included manufacturers, and the Part D weight-loss coverage exclusion would not apply. The drugs must fall under a plan’s basic benefit structure.
  • Prior authorization would also be standardized across the model. The documents outline body mass index thresholds, provider attestation and confirmation that patients are pursuing lifestyle modification.
  • The model is slated to begin in 2026 for Medicaid and 2027 for Medicare Part D.
  • In December, CMS published a request for applications directed to manufacturers, as well.
  • Press: https://www.beckerspayer.com/policy-updates/cms-invites-medicare-part-d-plans-medicaid-agencies-to-apply-for-glp-1-affordability-model/
  • Medicare Part D: https://www.cms.gov/priorities/innovation/files/balance-part-d-plans-rfa.pdf
  • Medicaid: https://www.cms.gov/priorities/innovation/files/balance-state-medicaid-rfa.pdf

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

Lawsuit seeks details on Medicare immigrant curbs

  • Why it matters: Last year's GOP tax-and-spending law stripped coverage from an estimated 100,000 immigrants covered by Medicare.
    • Federal officials haven't released guidance on how the prohibition will be enforced, according to the Center for Medicare Advocacy, which filed the lawsuit in a federal court in Connecticut last week.
  • Driving the news: Refugees, immigrants who've survived trafficking or domestic violence and individuals allowed to temporarily enter the country for emergency reasons starting in January will be dropped from Medicare.
    • The government already is turning away new applicants in those categories.
    • The Center for Medicare Advocacy submitted a Freedom of Information Act request in September asking Medicare and Social Security officials to release records related to the changes. But the government denied the request for quick processing and hasn't sent any records, CMA says.
    • The lawsuit seeks the records before the current period where enrollees have a final chance to switch their Medicare coverage on March 31.
  • What they're saying: The lack of guidance may keeping eligible seniors out of Medicare, CMA argued in its complaint.
    • "Every day that passes without transparency increases the likelihood that eligible individuals will be deterred from enrolling, leading to permanent financial liability or a total loss of access to health benefits," the lawsuit says.
  • https://www.axios.com/2026/03/09/medicare-eligibility-restrictions-immigrants   (subscription required for full text)      

RFK Jr.’s advisers had a plan to target COVID shots. Then it fell apart.

  • A key federal vaccine advisory panel has abandoned an attack on the covid-19 mRNA vaccines — a shift that comes as some Republicans warn that any more changes to vaccine policy could damage the party in the midterms.
  • Some of Health and Human Services Secretary Robert F. Kennedy Jr.’s handpicked vaccine advisers had been seeking to potentially stop recommending mRNA shots.
  • That plan is no longer moving forward, according to two people familiar with the matter who spoke on the condition of anonymity to describe internal deliberations.
  • In recent months, some members of the Advisory Committee on Immunization Practices (ACIP) have publicly questioned the safety and manufacturing of the shots, including raising a debunked theory that DNA contaminants in the vaccines were harmful.
  • One option under consideration was a potential vote to withdraw the federal recommendation for covid-19 mRNA vaccines altogether because of those objections, according to multiple people familiar with deliberations who spoke on the condition of anonymity due to the sensitivity of the matter. Such a change could throw into doubt how long insurers would continue to cover the shots for free and whether pharmacies would continue to carry them.
  • https://www.washingtonpost.com/health/2026/03/11/covid-vaccine-recommendation-panel/   (subscription required for full text)      

Trump administration starts new process to try to replace tariffs struck down by Supreme Court

  • The Trump administration on Wednesday opened a new trade investigation into manufacturing in foreign countries — an effort that comes after the Supreme Court struck down President Donald Trump's previous use of tariffs by declaring an economic emergency.
  • Trump and his team have made clear that they're seeking to replace the hundreds of billions of dollars in lost revenues after the Supreme Court's February ruling by using different laws to establish new tariffs.
  • In this case, the administration is starting investigations under Section 301 of the Trade Act of 1974, which could eventually lead to new import taxes. But U.S. Trade Representative Jamieson Greer, in a Wednesday call with reporters, said he didn't want to prejudge the outcome of the process.
  • "The policy remains the same — the tools may change depending on, you know, the vagaries of courts and other things," said Greer, stressing that the goal was to protect American jobs.
  • Greer indicated that there could be additional Section 301 investigations over issues such as digital service taxes, pharmaceutical drug pricing and ocean pollution, among other possibilities. The Commerce Department has separate trade investigations under Section 232 of the 1962 Trade Expansion Act.
  • https://www.pbs.org/newshour/politics/trump-administration-starts-new-process-to-try-to-replace-tariffs-struck-down-by-supreme-court

KEY BIOPHARMA NEWS

FDA proposes to ease testing rules to speed up biosimilar drug development

  • The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions of complex ​biologic medicines, aiming to lower the cost of treatments for diseases ‌such as cancer and autoimmune disorders.
  • Biologic medicines, made from living cells, are among the most expensive drugs on the market. While they make up about 5% of prescriptions, ​they account for 51% of drug spending, the U.S. Food ​and Drug Administration said.
  • The agency, in the draft guidance, recommended streamlining ⁠certain studies testing how the body interacts with a drug when ​there is enough scientific evidence.
  • It said the change could reduce pharmacokinetic study ​costs for biosimilar developers by up to 50%, or about $20 million.
  • According to the draft guidance, companies may, in some cases, use clinical data based on a comparable version of the original drug approved outside the United States ​without running an ​additional three-way study ⁠involving the proposed biosimilar, the U.S.-licensed reference drug and the foreign comparator.
  • The agency also said it was withdrawing a ​2015 guidance on how to show that a biosimilar ​matches its ⁠reference medicine, saying the document no longer reflects its current thinking after years of reviewing such applications.
  • Press: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-ease-testing-rules-speed-biosimilar-approvals-bloomberg-news-reports-2026-03-09/
  • FDA press: https://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-streamline-biosimilar-development-and-make-medicines-more-affordable

GOP senator is investigating the FDA over rejections of rare disease drugs

  • Sen. Ron Johnson (R-Wis.) said he is investigating the Food and Drug Administration’s rejections of rare disease treatments.
  • The Wisconsin Republican is requesting denial letters, called complete response letters, that the FDA sent to makers of rare disease treatments for conditions including ataxia and Sanfilippo syndrome. He said he’s heard that some of the issues in those letters are “nitpicky things.”
  • “We’re going to find out exactly what issues the FDA listed for their ‘nos’,” he said.
  • https://www.statnews.com/2026/03/10/ron-johnson-investigating-fda-rare-disease-drug-denials/   (subscription required for full text)      

FDA to end 9-month advisory committee drought with April review of AstraZeneca's oral SERD, Truqap

  • The FDA will end a roughly nine-month hiatus of drug-related advisory committee meetings, with plans to convene its first session of 2026 to scrutinize a pair of oncology applications from AstraZeneca.
  • The scheduled dual-session meeting marks the agency’s first adcomm for a drug since July…that would translate into a nine-month void barring any surprise last-minute additions.
  • The April 30 assembly will also be the first ODAC meeting after longtime FDA oncology czar Richard Pazdur, M.D., suddenly retired from the agency at the end of 2025, leaving cancer drug developers and the broader biopharma industry in shock.
  • At a time when the new administration’s FDA policies have sparked questions over regulatory consistency, the agency’s oncology division could offer a sense of continuity.
  • Replacing Pazdur as acting director of the Oncology Center of Excellence (OCE) is division veteran R. Angelo de Claro, M.D., who began working at the FDA’s Office of Hematology and Oncology Products in 2010. He was most recently Pazdur’s second-in-command, serving briefly as deputy director of the OCE and deputy office director of the Office of Oncologic Diseases before the promotion.
  • https://www.fiercebiotech.com/biotech/fda-end-8-month-advisory-committee-drought-april-review-astrazenecas-oral-serd-truqap

FDA, states review plans to import drugs from Canada

  • The FDA recently met with several states to discuss the Section 804 Importation Program, which allows states and tribes to propose plans to import certain lower-cost prescription drugs from Canada.
  • The meeting — held with representatives from HHS and the National Academy for State Health Policy — was part of ongoing federal efforts to reduce drug prices and advance President Trump’s pricing agenda.
  • The program aligns with a broader “most-favored-nation” strategy that ties U.S. drug prices to those in other high-income countries. It also builds on recent agreements with major drugmakers, including Pfizer, AstraZeneca, Eli Lilly and Novo Nordisk. Those deals helped lay the groundwork for TrumpRx, a federal platform launched in February that sells discounted drugs directly to consumers, bypassing traditional pharmacy benefit managers.
  • https://www.beckershospitalreview.com/pharmacy/fda-states-collaborate-to-lower-drug-prices/

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

CMS Eyes Changes to Colorectal Cancer NCD by Lowering Patient Ages, Raising Test Performance

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

ARPA-H launches program to develop biosensors that can track multiple signals

  • The Advanced Research Projects Agency for Health, or ARPA-H, launched a new program on Tuesday to support development of biosensors that can track multiple signals such as inflammation markers, hormones or drug levels within the body.
  • The program, called Delphi, will focus on using electronic “chiplets,” with the goal of being able to “mix and match” features across wearables and ingestible sensors.
  • The initiative comes as Health and Human Services Secretary Robert F. Kennedy Jr. has emphasized a role for wearables in tracking health habits.
  • The program will run for four-and-a-half years, with plans to create initial prototypes in the first two years, then work on integrating components into working systems and regulatory applications, and finally clinical trials and human factors testing. In each of the three phases, developers will be challenged to add new biomarkers to their prototypes.
  • ARPA-H did not disclose funding amounts for the projects, but the official said that the agency typically awards milestone-based contracts, and past projects have been funded at $30 million up to $150 million.
  • Solution summaries are due on April 8, according to the program’s website.
  • Press: https://www.healthcaredive.com/news/arpa-h-launches-program-to-develop-biosensors-that-can-track-multiple-signa/814401
  • ARPA-H Press: https://arpa-h.gov/news-and-events/arpa-h-launches-program-supercharge-biosensor-device-development-next-generation

HHS officials offer updates on interoperability efforts, information blocking enforcement

  • The Department of Health and Human Services (HHS) is ramping up major federal interoperability initiatives on several fronts.
  • As part of this interoperability work, the Trump administration unveiled in July a sweeping health tech initiative that aims to modernize Medicare and advance next-generation digital health for patients, including conversational artificial intelligence, digital IDs and easier ways to access health data.
  • The Centers for Medicare & Medicaid Services (CMS) is spearheading an API-focused data exchange framework to enable sharing of patient medical records through a new initiative called the CMS Aligned Network. This work is meant to accelerate data sharing at a faster pace than can be achieved through regulations alone, according to Amy Gleason, acting administrator, U.S. DOGE Service, and strategic advisor to the CMS.
  • Since July, more than 700 healthcare organizations have joined the Health Tech Ecosystem pledge, which is completely voluntary, Gleason said.
  • The goal is to have tangible results from these pledges go live by March 31.
  • The CMS also set another deadline, July 4, for organizations to demonstrate more advanced functionalities and workflows, she noted.
  • The CMS Aligned Network is not meant to compete with TEFCA, Gleason said, referencing the government-backed health data sharing initiative that allows patients, providers and payers to share health records.
  • NOTE by HA: this information was announced at HIMSS26
  • https://www.fiercehealthcare.com/health-tech/himss26-hhs-officials-offer-updates-interoperability-efforts-information-blocking

CMS uses data analytics, collaboration to crack down on Medicare fraud

  • Federal health officials are taking a more aggressive, data-driven approach to combating healthcare fraud, using analytics and cross-agency collaboration to stop suspicious payments before taxpayer dollars leave the system, according to a panel at the 2026 HIMSS Global Health Conference & Exposition.
  • During the session, entitled "Rapid Response: Implementing the Fraud Defense Operations Center," leaders from the Centers for Medicare & Medicaid Services (CMS) described how the agency's Fraud Defense Operations Center (FDOC) is helping investigators identify high-risk providers and intervene in near real time.
  • Launched in 2025 by CMS' Center for Program Integrity, the initiative has already triaged more than 340 suspect providers and prevented more than $1.4 billion in potential payments while investigations continue, the panelists said.
  • Bethany Messick, deputy director of the Data Analytics and Systems Group at CMS' Center for Program Integrity, said the program was designed to address a long-standing problem in fraud enforcement: the lag between detecting suspicious activity and acting.
  • "In the past it was a tangled process, and these providers could try and take us for millions overnight," Messick said.
  • The FDOC brings analysts, investigators, clinicians, legal advisors and law enforcement partners into a shared environment where they can evaluate cases quickly and coordinate responses.
  • Fraud data analysts first identify suspicious patterns in claims and provider data, looking for indicators such as unusual billing relationships or affiliations between providers. Those leads are then prioritized based on the potential financial impact or risk to patients before being reviewed by clinical and regulatory experts.
  • https://www.mobihealthnews.com/news/cms-uses-data-analytics-collaboration-crack-down-medicare-fraud

The FDA is targeting telehealth marketing of GLP-1 drugs

  • The Food and Drug Administration is cracking down on telehealth companies’ marketing of compounded versions of weight loss drugs. In recent months, the agency has warned them against implying that their products are FDA approved, or that they themselves manufacture the products.
  • But those companies may not be the only ones under the microscope.
  • The telehealth companies that have been warned — with names like Lovely Meds, Hello Cake, and MEDVi — don’t directly prescribe the medications, which are not approved by the FDA or evaluated for safety and efficacy. That falls to the clinicians in medical groups affiliated with the companies. And a STAT analysis shows that cited companies can share clinical DNA.
  • Among more than 70 telehealth companies warned by the FDA in the last six months, at least 30% have publicly stated affiliations with just four nationwide medical groups: Beluga Health, OpenLoop, MD Integrations, and Telegra.
  • https://www.statnews.com/2026/03/12/fda-telehealth-marketing-glp1-prescribers-behind-warning-letters/   (subscription required for full text)      

Key Acronyms

  • ACA = Affordable Care Act
  • ACIP = Advisory Committee on Immunization Practices
  • AERS = Adverse Event Reporting System
  • ARPA-H = Advanced Research Projects Agency for Health
  • BALANCE = Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth
  • CCSQ = Center for Clinical Standards and Quality
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • CTPAE = Center for Tobacco Products Adverse Event Reporting System
  • DOGE = Department of Government Efficiency
  • FAERS = FDA Adverse Event Reporting
  • FDA = Food and Drug Administration
  • FDOC = Fraud Defense Operations Center
  • GAO = Government Accountability Office
  • HFCS = Human Foods Complaint System
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • IACC = Interagency Autism Coordinating Committee
  • JEC = Joint Economic Committee
  • MA = Medicare Advantage
  • MAHA = Make America Healthy Again
  • MAUDE = Manufacturer and User Facility Device Experience
  • NGO = non-governmental organization
  • NIH = National Institutes of Health
  • OPO = Organ Procurement Organization
  • QCOR = Quality, Certification and Oversight Reports
  • TEFCA = Trusted Exchange Framework and Common Agreement
  • TM = Traditional Medicare
  • VAERS = Vaccine Adverse Event Reporting System
  • VRBPAC = Vaccine and Related Biological Products Advisory Committee

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